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Nature in Harmony: Music and Nature-based Self-care for Individuals With Acquired Brain Injuries and Their Care Partners

28. april 2026 oppdatert av: Duquesne University

The goal of this pilot study is to determine the initial impact on wellbeing for clients with acquired brain injury and their care partner after engaging in a nature & music-based program facilitated by occupational therapy and music therapy. The main questions it aims to answer are:

  • Primary Question: What is the impact on wellbeing for clients with acquired brain injury and their care partner after engaging in a nature & music-based program facilitated by occupational therapy and music therapy?
  • Secondary Question: What is the feasibility of a four-session nature & music-based wellness program for clients with acquired brain injury and care partner dyads?

    • Attendance
    • Satisfaction
    • Accessibility
    • Carryover of Strategies

Participants will complete self-reported surveys before and after completing 4 sessions of a nature & music-based program facilitated by occupational therapy and music therapy.

Studieoversikt

Status

Påmelding etter invitasjon

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Antatt)

10

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

    • Pennsylvania
      • Pittsburgh, Pennsylvania, Forente stater, 15228
        • Duquesne University

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Ja

Beskrivelse

Inclusion Criteria:

  • All participants must be above the age of 18 to participate.
  • Able to communicate in English
  • A person with an ABI can include persons with a diagnosis of traumatic brain injury, stroke, aneurysm, brain infection, and/or brain cancer.
  • A care partner is broadly defined as a social support person who has been identified as a family member or friend of the person with the acquired brain injury.
  • Capacity for consent - Person must be their own medical power of attorney
  • Capacity for Self-Reflection (have a score of 23/35 on the MOCA or have a 5/6 on the Design Memory Test sub test of Cognition and Language Quick Test)

Exclusion Criteria:

  • Self-reported severe-to profound hearing loss with the use of hearing aid(s)
  • Cannot communicate in English
  • Have a diagnosis of a progressive neurological disorder, such as Amyotrophic lateral sclerosis, Parkinson's disease, Dementia, Multiple Sclerosis
  • Have a severe aphasia

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: N/A
  • Intervensjonsmodell: Enkeltgruppeoppdrag
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Nature In Harmony
The Nature in Harmony program involves four in-person sessions held at Duquesne University's campus using the outdoor pavilion and community garden with the final session occurring at Frick Park at their Environmental Center located in Pittsburgh, PA, between May and June of 2026. Each session will have a minimum of two principal investigators to lead the activities. Graduate assistants will be at each session to provide additional hands-on support for safety, mobility, and participant engagement. Participants will be instructed to complete carryover activities between sessions: one to be completed together dyadically (person with ABI & care partner) and one to be completed individually. Dyads will reflect on the experience in their activity journal and share and the beginning of sessions 2-4.
  • Session 1- Duquesne University -120 minutes- Building Rapport: Psychoeducation on Music & Nature
  • Session 2 - Duquesne University - 90 minutes - Using the Senses for Wellness
  • Session 3 - Duquesne University - 90 minutes - Connections & Community
  • Session 4 - Frick Park Environmental Center - 4 Hours including Lunch - Self Care Immersion in Nature Retreat

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
EUROHIS-QOL 8-item index
Tidsramme: First session to end of program approximately 4 weeks.
EUROHIS-QOL 8 is a standardized assessment of general quality of life that assesses four domains of QOL: physical, psychological, social, and environmental. This assessment has been validated for persons with traumatic brain injury (Balalla et al., 2019). This is 5-point scale from "not at all" to "completely." A high total point value indicates a better quality of life rating.
First session to end of program approximately 4 weeks.

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
The Connor-Davidson Resilience Scale
Tidsramme: First session to end of program approximately 4 weeks.
The 10-item Connor-Davidson Resilience Scale will be administered as a secondary outcome to determine if any impacts are seen after this brief program because of participation. This measure has been used with persons post-traumatic brain injury, stroke, and caregivers. Rating scale goes from 0-4 with higher total scores indicating better resilence.
First session to end of program approximately 4 weeks.
Dyadic Relationship Scale
Tidsramme: First day to end of program approximately 4 weeks
The 10-item Dyadic Relationship Scale will be administered as a secondary outcome to examine any changes in both positive and negative interactions between individuals with ABI and their care partners after this program (Sebern & Whitlatch, 2007). This is a four point scale with a higher score indicating more negative dyad experiences.
First day to end of program approximately 4 weeks
Client Satisfaction Questionnaire (CSQ-8)
Tidsramme: Last session, approximately 4 weeks after first session
This measure uses eight questions on a four point Likert-scale strongly agree to strongly disagree to assess participants' overall satisfaction with the program with a maximum score of 32 (Attkisson & Greenfield, 2004). The average score for the group on the CSQ-8 is at least 24.
Last session, approximately 4 weeks after first session
Attendance
Tidsramme: Every week for 4 weeks.
Session attendance will be tracked at every session throughout the program as either present "1" or absent "0". Participants who attend all sessions will have a total of 4.
Every week for 4 weeks.
Accessibility of the strategies
Tidsramme: Every week of the program for four weeks.
4-point Likert scale survey will be used to document participants' interest in using the covered strategies in the sessions. Items will not be totaled and scales vary by question.
Every week of the program for four weeks.
Carryover of the strategies
Tidsramme: Weekly journal entries for weeks 2,3, and 4.
A self-reported journal includes date, the name of the activity, length, and personnels will be provided for documenting the carryover activities outside of the session time.
Weekly journal entries for weeks 2,3, and 4.

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

4. mars 2026

Primær fullføring (Antatt)

21. mai 2026

Studiet fullført (Antatt)

1. juni 2026

Datoer for studieregistrering

Først innsendt

21. april 2026

Først innsendt som oppfylte QC-kriteriene

28. april 2026

Først lagt ut (Faktiske)

5. mai 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

5. mai 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

28. april 2026

Sist bekreftet

1. april 2026

Mer informasjon

Begreper knyttet til denne studien

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

IPD-planbeskrivelse

This was not included in the original IRB due to the small and local nature of the sample.

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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